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- Klinische proef NCT00353249
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Homeless Women
Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Exposure to traumatic events may lead to mental health problems, such as post-traumatic stress disorder (PTSD). PTSD is a type of anxiety disorder that is characterized by the presence of persistent frightening thoughts and memories of the traumatic event. Additionally, people with PTSD often feel emotionally numb, and they may experience sleep problems or be easily startled. Homeless people, in particular, are at risk for experiencing a variety of traumas. Homeless women tend to experience more traumatic events and develop PTSD at higher rates than housed women. Although effective treatments for PTSD are available, homeless women are unlikely to seek them out. There is a need for PTSD treatment approaches that are specifically designed for these women. This study will develop a cognitive-behavioral therapy treatment that will be adapted to best serve the needs of homeless women. The study will then determine the therapy's effectiveness in treating a group of homeless women with PTSD.
This study will consist of three phases. The first phase will be used to gather and analyze information about PTSD in homeless women and methods of treating the disorder in this population. Focus groups consisting of homeless women, shelter directors, case managers, and mental health service providers will be used to obtain the necessary information. Phase two of this study will consist of developing an adaptation of an existing PTSD treatment manual to make it relevant to the lives of homeless women. The third and final phase of this study will recruit 32 homeless women with symptoms of PTSD, and who did not participate in either of the first two phases of the study. Participants in this 4-week study will be randomly assigned to receive either the adapted cognitive behavioral therapy treatment or no treatment at all (assessment-only). The treatment group will attend twice weekly sessions for a total of 4 weeks. All participants will be evaluated immediately prior to the start of treatment and 1 week after treatment ends. Outcomes will include PTSD symptoms and depression symptoms.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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California
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Los Angeles County, California, Verenigde Staten
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Sub-diagnostic threshold PTSD symptoms
- Currently resides in a transitional homeless shelter in Los Angeles County
- Trauma that is related to PTSD symptoms occurred at least 1 month prior to study entry
- Understands, speaks, and reads English
- Planned departure date from the shelter is at least 1 month after study entry
Exclusion Criteria:
- Significant cognitive impairment
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
Participants will receive adapted cognitive behavioral therapy treatment
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Adapted CBT is a group treatment for PTSD and will occur two times per week for 4 weeks.
The sessions will last 90-minutes and will be led by a therapist and co-therapist.
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Geen tussenkomst: 2
Participants will receive no treatment for the course of the study; they will be offered courtesy PTSD 5 weeks after the experimental intervention.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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PTSD symptoms
Tijdsspanne: Measured at Week 4
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Measured at Week 4
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Depression symptoms
Tijdsspanne: Measured at Week 4
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Measured at Week 4
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Suzanne Wenzel, PhD, RAND
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R34MH076099 (Subsidie/contract van de Amerikaanse NIH)
- DSIR 82-SEMS (Andere identificatie: National Institute of Mental Health)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Adapted cognitive behavioral therapy (CBT)
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Nova Scotia Health AuthorityVoltooid
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Linnaeus UniversityKronoberg County Council; Capio GroupVoltooidKwaliteit van het leven | Spanning | Slapeloosheid | Psychische nood | Depressie, angst | Activiteiten, dagelijks levenZweden
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Dartmouth-Hitchcock Medical CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)VoltooidAlcohol misbruikVerenigde Staten
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Gkouskou KalliopiOnbekend
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Chestnut Health SystemsNational Institute on Drug Abuse (NIDA)VoltooidDrugsmisbruik | Substantie afhankelijkheidVerenigde Staten
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Mayo ClinicVoltooidObsessief-compulsieve stoornis | Angst stoornissenVerenigde Staten
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University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Johns Hopkins University; Thai Nguyen...VoltooidAlcohol drinken | HivVietnam